Safety and Efficacy Study for a New Antiviral Drug to Treat Genital Herpes Type 2 (NCT01047540) | Clinical Trial Compass
CompletedPhase 2
Safety and Efficacy Study for a New Antiviral Drug to Treat Genital Herpes Type 2
United States156 participantsStarted 2010-03
Plain-language summary
The aim of the study is to find out whether AIC316 is safe and efficacious for the prevention of reactivation of genital herpes
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult, Immunocompetent men and women in good health of any ethnic group
* History of recurrent episodes of genital herpes for at least 12 months
* Seropositive for Herpes Simplex Virus HSV Type 2
* Body Mass Index (BMI) between 18 and 35 kg/m2
Exclusion Criteria:
* Present episode of genital herpes
* Intake of systemic drug against HSV or any topical application against HSV within 7 days before randomization for the trial
* Intake of systemic corticosteroids, other immunomodulating agents or any investigational agent within 3 months before randomization for the trial
* Positive results in any of the virology tests for human immunodeficiency virus antibody (HIV-Ab), hepatitis C antibody (HCV-Ab), hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBc-Ab)
What they're measuring
1
Efficacy of 4 Different Doses of AIC316 and Matching Placebo With Respect to the Suppression of Herpes Simplex Virus Replication (Shedding Rate)